Health Ministry Clarifies Drug Registration Process For ‘Ozempic’

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The Ministry of Health said it notes with concern the editorial published in the Express newspaper today (Wednesday 29th January, 2025), regarding the drug ‘Ozempic.’ The Ministry said it “wishes to categorically state that there are no bureaucratic delays (‘red tape’) preventing the approval of ‘Ozempic’ or any other drug.”

In a Media Release today, the Ministry states that, “The registration of pharmaceutical products in Trinidad and Tobago is governed by the Food and Drugs Act, Chapter 30:01 and Regulations made thereunder, Division 3-New Drugs, which outlines the requirements to register a drug. This includes the completion and submission of an application form along with technical drug documentation. It must be noted that the onus for submission of an application lies with the Importer/Distributor and not the MOH. Submissions undergo a rigorous screening process to ensure compliance with safety, quality and efficacy standards before any drug is approved for public use.”

The Ministry said it “confirms that at this time there is no application from the local registered distributor for Novo Nordisk for the registration of ‘Ozempic.’ However, an application for a generic version has been received. To safeguard the public’s interest, the MOH, as part of its standard operating procedure when questions of patents arise, has been communicating with the local Intellectual Property Office, the manufacturer, Novo Nordisk and its local distributor, Alstons Marketing Company Limited (AMCO). This is to determine whether or not a patent exists at this time in Trinidad and Tobago for ‘Ozempic.’“

The Ministry is reminding the public that it “remains the competent authority responsible for ensuring the safety, quality, and efficacy of all medications available in Trinidad and Tobago and we urge the media to exercise due diligence when disseminating information to the public.”

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